Quality Specialist II, Post Market Surveillance (PMS) and Stability will provide support in preparation of data analysis, reporting, trending, and documentation review, coordination of complaint and lot qualification data, device history reviews and review and closure of certain categories of complaints. It requires regulatory assessment capability along with MDR/Vigilance reporting. The Post Market Surveillance Specialist may also review and monitor data and document quality, as requested by the manager.
Product Complaints:
duties and responsibilities include, but are not limited to the following:
and analyze lot documentation (DHR's) to determine if there are any anomalies that may have related to reported product failures.
basic product review and failure analysis.
risk management plan, facilitate risk analysis and assessment per Risk Management Policy, monitoring and compiling data from adverse events, customer inquiries, complaint records, CAPAs, deviation reports, stability reporting, non-conformance reports, PERs, PCRs, recalls, scientific literature searches, clinical performance, and proficiency testing.
Product Stability:
and performs various stability testing in accordance with stability protocols.
stability samples are available and placed in stability chambers at the appropriate time frames to meet the requirements of the stability protocol.
stability samples are pulled at the appropriate time frames to meet requirements of the stability protocol.
stability test data utilizing the department stability software program.
Risk and PMS manager with summarizing stability data for submission into the final stability report.
testing and data analysis is completed in a timely manner to meet business and regulatory deadlines.
Out of Specification results and notifies manager in a timely manner.
manager immediately when adverse stability data trends are identified.
stability chambers are maintained and calibrated according to internal and external quality and regulatory requirements.
Product Development Risk Review:
and facilitate product development and change risk reviews.
with Post Market Surveillance department functions as needed. (Specific duties may vary and will be documented in department records, job assignments and/or project action items).
computer operations for data entry and provide tracing/trending reports. Abide by corporate policies, procedures and work instructions.
during FDA, ISO or other third party or internal audits. Other duties as assigned.
Minimum Requirements:
degree in Biological Sciences or a related field.
years of experience in a Quality regulated environment.
to create presentations, work with spreadsheets, prepare reports and write procedures utilizing MS Word, Excel and PowerPoint software applications.